Magnesium and Riboflavin Treatment for Post-Concussion Headache

Concussion, Intermediate Clinical Trial

Official title:

Magnesium and Riboflavin Treatment for Post-Concussion Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260072
• Other study ID #: IRB-HSR 21920
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Virginia
• Contact: Stephanie Hartman, MD
• Phone: 434-924-5362
• Email: slm8nh[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion;

• Less than 3 days have elapsed since their injury;

• Able to swallow capsules

Exclusion Criteria:

• Concussion complicated by cranial bleed, skull fracture, additional severe injury;

• Kidney disfunction or failure;

• Significant gastro-intestinal dysfunction;

• Varsity Athlete;

• Two or more previous concussions;

• Women who are pregnant or breast feeding;

• Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Intermediate
• Headache

Intervention

Drug:
• magnesium and riboflavin supplement
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)

Locations

Country	Name	City	State
United States	University of Virginia Student Health and Wellness Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Intensity and Duration	t-test of mean differences between the groups	14 days